Trial for Treatment Refractory Trigeminal Neuralgia
Johns Hopkins Clinical Research Study
Study Description:
What is the purpose of this study?
The purpose of this research study is to determine the effectiveness of the drug Rimegepant in the treatment of people with Trigeminal Neuralgia.
Who can participate?
People with trigeminal neuralgia who have had an inadequate response to other treatments may join.
What will happen if you join this study?
Total study duration is about 9 weeks. Participants will undergo a 2-week screening that includes a clinic visit, blood draw, ECG, physical and neurological exams, survey about your thoughts about suicide, medication and medical history review, and tests for pregnancy, drugs of abuse, HIV and Hepatitis.
During your participation, you may be asked to stop certain medications you currently take for trigeminal neuralgia.
Once screening is complete, participants will start the study drug administration phase that can last up to five weeks. All participants will receive the drug Rimegepant and placebo. At some point during the 5-week treatment period there is a 100% chance you will be assigned “Rimegepant” and a 100% chance that you will be assigned matching placebo. When you receive “Rimegepant” or matching placebo during that time period will be decided by chance (like flipping a coin). During study drug administration you will return for a clinic visit similar to the screening visit four times in those five weeks. Participants will also be asked to complete a daily pain and drug diary. Participants will return for their last visit two weeks after study drug administration ends.
There will be about six visits over the course of the 9-week study duration. There are risks to this study drug that the study team will describe to you.
The study is being conducted for Biohaven Pharmaceuticals, Inc. (BHV). Your study doctor is being paid by BHV to conduct this study.
Eligibility Criteria:
Key Inclusion Criteria
- diagnosis of trigeminal neuralgia with symptoms lasting at least 3 months
- inadequate response to current treatment
- no other cause found on imaging
- normal neurological exam
- on stable doses of all medications for at least 3 months
- 3 months since any prior procedures to treat trigeminal neuralgia
- Age >= 18
- women must not be pregnant, planning to become pregnant during the study period, or breastfeeding
- no other uncontrolled medical conditions
- cannot have a history of gallstones or gallbladder removal
There are other inclusion and exclusion criteria that will be reviewed by the study team before enrollment.
Recruitment Contact Name: Whitney Isennock
Contact Phone: 410-955-7008
Contact E-mail: wwebb10@jhmi.edu
Location of Study Visits
Arizona
Gilbert Neurology Partners/CCT Research
Gilbert, Arizona, United States, 85297
Contact: Jessica Padilla 602-761-9631 jessicapadilla@cctresearch.com
California
Center for Neurohealth: Kaizen Brain Center
La Jolla, California, United States, 92037
Contact: Nancy Tomka 858-294-0161 research@kaizenbraincenter.com
Stanford University
Stanford, California, United States, 94305
Contact: Anthony Bet 650-683-5823 abet0915@stanford.edu
Florida
SouthCoast Research Center
Miami, Florida, United States, 33136
Contact: Lourdes Martinez 786-343-6937 sc2@southresearch.org
Louisiana
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Contact: Colleen Dionne 504-894-2864 colleen.dionne@ochsner.org
Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Contact: Whitney Isennock 410-955-7008 wwebb10@jhmi.edu
Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
Contact: Malana Kanallakan 636-220-1200 recruitment@clinicalresearchprofessionals.net
New York
Dent Neurological Institute
Amherst, New York, United States, 14226
Contact: Rebecca Hogan 716-558-5670 rhogan@dentinstitute.com
Neurological Surgery, PC
Lake Success, New York, United States, 11042
Contact: Stephanie Ramjattan 516-478-0008 sramjattan@nspc.com
North Suffolk Neurology
Port Jefferson Station, New York, United States, 11776
Contact: Matthew Kluko 631-629-8810 mkluko@nsneuro.net
Ohio
Neurology Diagnostics Inc.
Dayton, Ohio, United States, 45459
Contact: Taylor Rhodes 937-224-8200 taylor.rhodes@neurologydiagnostics.com
Study will provide compensation: No
